Electroencephalographic Patterns of Septic Patients and Its Correlation With Cognitive Outcomes

NCT ID: NCT05448534

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-02-24

Brief Summary

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The investigators evaluated the electroencephalographic pattern by the Sinek and Young scales during ICU stay and its correlation with cognitive impairment determined by the Montreal Cognitive Assessment (MOCA) in septic patients after 3 months of ICU discharge..

Detailed Description

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The investigators prospectively evaluate patients with sepsis and septic shock expected to stay in the intensive care unit (ICU) for at least 4 days. We used Sinek and Young scales to classify electroencephalographic patterns during ICU stay (in the first 24 hours after admission and in the third ICU day) and correlate with cognitive outcome evaluated with MOCA score 3 months after ICU discharge. The investigators evaluate as primary outcome the association between electroencephalographic abnormalities and cognitive dysfunction measured by the Montreal Cognitive Assessment (MoCA) 3 months after ICU discharge and secondary outcomes as association between electroencephalographic patterns and 28 days mortality, Quality of Life (SF-36) after 3 months of discharge, ventilator free days, vasoactive drug free days and Glasgow outcome scale.

Conditions

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Eletroencephalography

We used Sinek and Young Scale to classify electroencephalographic patterns and cognitive outcome with MOCA score.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Montreal Cognitive Assessment (MoCA) Sinek and young scales

Eligibility Criteria

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Inclusion Criteria

Included were patients aged above 18 years, who were expected to stay in the ICU for at least 4 days, between November 2021 and November 2022.

\-

Exclusion Criteria

* CNS infections,
* Structural abnormalities of the CNS, known
* Liver or uremic encephalopathy,
* Advanced dementia (Mini mental \< 9),
* Psychiatric disorder
* Epilepsy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Sao Domingos

OTHER

Sponsor Role lead

Responsible Party

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José Raimundo Araujo de Azevedo

ICU Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JOSE AZEVEDO, MD, PhD

Role: STUDY_DIRECTOR

Hospital Sao Domingos

Locations

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Icu Hospital Sao Domingos

São Luís, Maranhão, Brazil

Site Status

Countries

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Brazil

References

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Azabou E, Magalhaes E, Braconnier A, Yahiaoui L, Moneger G, Heming N, Annane D, Mantz J, Chretien F, Durand MC, Lofaso F, Porcher R, Sharshar T; Groupe d'Explorations Neurologiques en Reanimation (GENER). Early Standard Electroencephalogram Abnormalities Predict Mortality in Septic Intensive Care Unit Patients. PLoS One. 2015 Oct 8;10(10):e0139969. doi: 10.1371/journal.pone.0139969. eCollection 2015.

Reference Type RESULT
PMID: 26447697 (View on PubMed)

Eidelman LA, Putterman D, Putterman C, Sprung CL. The spectrum of septic encephalopathy. Definitions, etiologies, and mortalities. JAMA. 1996 Feb 14;275(6):470-3.

Reference Type RESULT
PMID: 8627969 (View on PubMed)

Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010 Oct 27;304(16):1787-94. doi: 10.1001/jama.2010.1553.

Reference Type RESULT
PMID: 20978258 (View on PubMed)

Oddo M, Carrera E, Claassen J, Mayer SA, Hirsch LJ. Continuous electroencephalography in the medical intensive care unit. Crit Care Med. 2009 Jun;37(6):2051-6. doi: 10.1097/CCM.0b013e3181a00604.

Reference Type RESULT
PMID: 19384197 (View on PubMed)

Young GB, Bolton CF, Archibald YM, Austin TW, Wells GA. The electroencephalogram in sepsis-associated encephalopathy. J Clin Neurophysiol. 1992 Jan;9(1):145-52. doi: 10.1097/00004691-199201000-00016.

Reference Type RESULT
PMID: 1552002 (View on PubMed)

Hosokawa K, Gaspard N, Su F, Oddo M, Vincent JL, Taccone FS. Clinical neurophysiological assessment of sepsis-associated brain dysfunction: a systematic review. Crit Care. 2014 Dec 8;18(6):674. doi: 10.1186/s13054-014-0674-y.

Reference Type RESULT
PMID: 25482125 (View on PubMed)

Other Identifiers

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54

Identifier Type: -

Identifier Source: org_study_id

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